Study Investigates Effects of Patient Blood Management Program with Masimo SpHb®, Noninvasive, Continuous Hemoglobin Monitoring, on Postoperative Cancer Patients

(BUSINESS WIRE) -- Masimo (NASDAQ: MASI) announced today the findings of a study published in Blood Transfusion in which Dr. Lucia Merolle and colleagues at the Azienda USL-IRCCS of Reggio Emilia, Italy investigated the impact of applying a patient blood management program, including use of noninvasive and continuous hemoglobin monitoring, Masimo SpHb^®, to the care of postoperative cancer patients.¹ The study found that using SpHb as part of a patient blood management program not only increased how often postoperative blood transfusions were appropriate, but decreased the total and mean number of blood units transfused per patient.

Patient blood management (PBM) is “an evidence-based, multidisciplinary approach aimed at optimizing the care of patients who might need blood transfusions.” Recognizing that PBM might have specific benefits for surgical oncology patients, the researchers implemented a two-step PBM program and compared three groups of postoperative adult cancer patients who underwent major surgery between 2014 and 2017. Step 1 PBM included seminars and training designed to teach semi-intensive post-surgical personnel the principles of PBM. Step 2 PBM added the use of SpHb monitored with Masimo Radical-7^® Pulse CO-Oximeters^® with SpHb. Audit 1 reviewed data for 200 patients whose post-surgical care did not incorporate PBM. Audit 2 was of 200 patients whose care incorporated Stage 1 PBM, and Audit 3 was of 200 patients whose care incorporated Stage 2 PBM along with continuous SpHb monitoring.

Using guidelines developed by the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI), the researchers found that transfusion appropriateness rose from 38% in Audit 1 patients, to 75% in Audit 2 patients (Step 1 PBM), to 79% in Audit 3 patients (Step 2 PBM, with SpHb). The total number of red blood cell (RBC) units transfused was similar for Audit 1 and Audit 2 patients (52 and 58 units, respectively), but dropped to 39 units with the addition of SpHb monitoring to PBM (Audit 3). The mean number of RBC units transfused was the same for Audit 1 and Audit 2 patients (1.8 units/patient), but again, with the addition of SpHb monitoring (Audit 3), the mean dropped to 1.3 units/patient.

The researchers concluded, “Our PBM bundle positively impacted RBC transfusion appropriateness in post-surgical cancer patients, both in terms of quality and quantity. A structured PBM program specifically dedicated to surgical oncology should cover the entire perioperative period and might further improve transfusion appropriateness in these patients. The publication of guidelines on the management of anemia in surgical oncology should be a priority.”

In other clinical studies, continuous monitoring with SpHb as part of PBM programs has been found to improve outcomes, such as reducing the percentage of patients receiving transfusions,² reducing the units of red blood cells transfused per patient,^3-4 reducing the time to transfusion,⁵ reducing costs,⁶ and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively.⁷ With the addition of the Italian study, the evidence of SpHb’s impact on outcomes spans the globe, representing 6 countries on 4 different continents.^1-7 Today, SpHb technology supports clinicians in over 75 countries around the world.⁸

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹⁰ improve CCHD screening in newborns,¹¹ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^12-15 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁶ and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.¹⁷ Masimo continues to refine SET^® and in 2018, announced that SpO₂ accuracy on RD SET^® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^® and Radius PPG™, portable devices like Rad-67™, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris Gateway^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Merolle L, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez T, Baricchi R, Bonini A. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.

2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.

3. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.

4. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.

5. Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.

6. Ribed-Sánchez B et al. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.

7. Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.

8. Masimo data on file.

9. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.

10. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.

11. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.

12. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.

13. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

14. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

15. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

16. Estimate: Masimo data on file.

17. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

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